Arazy Group

What Arazy Group does

Arazy Group Consultants Inc. is a Vancouver-based, privately held international regulatory consultancy founded in 1995 that serves medical device and in vitro diagnostic (IVD) manufacturers seeking global market access. The company operates a dual-product platform: LICENSALE®, an expert-managed end-to-end regulatory consulting service for submission preparation and product approvals, and REGISLATE®, a SaaS Registration Management Software (RMS) covering Regulatory Information Management, Regulatory Process Management, and Regulatory Strategy Management across 140+ countries. Underlying technology combines an AI-powered regulatory affairs platform with machine learning data processing that the company claims generates device-specific registration compliance files in under one minute and automates up to 80% of compliance data using prior submission data.

The business model blends subscription recurring revenue (annual SaaS subscriptions for Initial, Amendment, Renewal, and Transfer country registrations) with professional services revenue (expert-managed submissions, EU Authorized Representative / UK Responsible Person / Swiss Representative / PRRC services through German and Irish offices). Pricing is quote-based rather than publicly disclosed, with auto-renewing subscriptions and multi-year contracts for expert user seats. Go-to-market combines a product-led growth motion via free trials scheduled through HubSpot with enterprise field sales targeting larger MedTech manufacturers, supported in English, French, Spanish, and Japanese.

The company reports 2,500 client companies, 5,000 applications processed, a 99% market clearance success rate since 2012, and claims up to 75% reduction in labour time and compliance costs. It holds ISO 9001 certification valid through October 2026 and operates physical offices in Vancouver (headquarters), Germany, and Ireland, with a global footprint covering North America, Europe, the Middle East, Africa, Asia-Pacific, and Latin America. The firm is bootstrapped, with no disclosed institutional investors beyond a 2013 Canadian Technology Accelerator program, and is led by founder Benjamin Arazy.

Name

Arazy Group

Legal name

Arazy Group Consultants Inc.

Website

https://arazygroup.com

Company type

Private

Founded year

1995

Operating status

Operating

Headcount range

101–250 employees

Short description

Arazy Group is a Vancouver-based regulatory consultancy founded in 1995 that provides AI-powered compliance software (REGISLATE®) and expert-managed regulatory services (LICENSALE®) for medical device and IVD manufacturers seeking market access across 140+ countries.

Ownership category

akta.pro rank

Product category

MedTech Regulatory Compliance Software

NAICS

Software Publishers (5132), Management Consulting Services (54161)

akta.pro primary industry

Regulatory Strategy & Global Submissions (IND/CTA/NDA/BLA/MAA) (HLAGAKAA)

akta.pro secondary industries

Regulatory Operations & Publishing (eCTD, RIM, Submission Management) (HLAGAKAC), Medical Writing & Regulatory Submission Support CROs (HLAGAAAG)

Keywords

• Regulatory affairs software
• Medical device registration
• IVD compliance solutions
• Regulatory consulting services
• Market access platform

Headquarters

HQ city

Vancouver

HQ country

Canada

HQ region

North America

Offices4 records

Markets served

GTM type

B2B

Offering type

Software

Cost components

Personnel, Technology or R&D, Operations, Marketing or Sales, Infrastructure

Revenue model

1. REGISLATE® SaaS Subscriptions: REGISLATE® is a regulatory management SaaS solution for large-scale processing, submission, and review of regulated medical and IVD product market access applications. Clients pay subscription fees for access to the platform with various tiers including Initial, Amendment, Renewal, and Transfer country-specific registration services. Subscriptions auto-renew and include 12 months of LICENSALE 2.0 SaaS access, online training, and customer support.
2. LICENSALE® Expert Services: End-to-end regulatory consulting services for manufacturers seeking expert-managed submissions and product approvals. Available through separate LICENSALE contract, providing expert regulatory guidance for smooth product approvals and fast market entry.
3. European Regulatory Representative Services: EU Authorized Representative (EU-AR), UK Responsible Person (UK-REP), Swiss Representative, and Person Responsible for Regulatory Compliance (PRRC) services with 30 years of experience with EU, UK, and Irish competent authorities.
4. Data Storage and Management: Additional data storage and management services for new LICENSALE clients requiring extended data retention and document management capabilities.

Pricing tiers

Go-to-market motion2 records

Distribution channels4 records

Marketing channels10 records

Core offering

Arazy Group provides AI-powered regulatory affairs technology and consulting for medical device and IVD manufacturers, enabling device-specific registrations across 140+ countries. Its offering combines REGISLATE®, a SaaS Registration Management Software that automates compliance workflows and generates submission files in under one minute, with LICENSALE®, an expert-managed consulting service that handles end-to-end regulatory submissions on behalf of manufacturers. The company also acts as an EU Authorized Representative, UK Responsible Person, Swiss Representative, and PRRC for non-EU manufacturers seeking European market access.

Product overview

Arazy Group offers a dual-product platform for global MedTech regulatory compliance: LICENSALE® provides expert-managed end-to-end regulatory consulting and submission services, while REGISLATE® is a self-service Registration Management Software (RMS) that enables manufacturers to handle regulatory affairs in-house. Both products operate on the same AI-powered platform technology, with REGISLATE covering RIM, RPM, and RSM functions across 140+ countries. The platform leverages AI to generate device-specific registration files, automate compliance workflows, and manage up to 80% of compliance data automatically. The company also provides European Regulatory Representative Services (EU AR, UK REP, Swiss REP) as a supplementary service offering.

Differentiator

Problem solved

Functional benefit

Brands

• LICENSALE®: End-to-end regulatory consulting solution for medical and IVD device companies, providing expert guidance for market approvals and product registration.
• REGISLATE®

Products and services

• LICENSALE® End-to-end regulatory consulting service providing expert-managed submissions and product approvals for medical device and IVD manufacturers, delivered through a separate LICENSALE® contract and targeted at companies that prefer outsourced regulatory execution.
• REGISLATE® SaaS Registration Management Software (RMS) for medical device and IVD manufacturers that enables in-house management of global registrations across 140+ countries. Covers Regulatory Information Management (RIM), Regulatory Process Management (RPM), and Regulatory Strategy Management (RSM), with subscription tiers for Initial, Amendment, Renewal, and Transfer country-specific registrations.
• European Regulatory Representative Services Statutory representation services for non-EU manufacturers, including EU Authorized Representative (EU-AR), UK Responsible Person (UK-REP), Swiss Representative (CH-REP), and Person Responsible for Regulatory Compliance (PRRC). Delivered through Arazy Group's German and Irish offices with 30 years of experience working with EU, UK, and Irish competent authorities.

Quantifiable outcome

• 99% market clearance success rate since 2012
• +4 more outcomes

Segments5 records

Ideal customer profiles4 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

AI capability4 records

Feature6 records

Scale indicators8 records

Recent moves6 records

Expansion highlights5 records

Emerging players

• Cognidox: Cognidox provides document and regulatory management software for medical device and life sciences companies, including submission tracking and compliance workflows. It overlaps with Arazy Group's SaaS platform as a focused regulatory document/submission management solution.

Direct peers

• ComplianceQuest: ComplianceQuest provides a cloud QMS and regulatory compliance platform built on Salesforce for medical device manufacturers. It competes with Arazy Group for MedTech regulatory software budgets, with emphasis on integrated quality and compliance management.
• Dot Compliance: Dot Compliance offers AI-driven quality and regulatory compliance solutions for life sciences, including MedTech QMS and submission management. It overlaps with Arazy Group's automated compliance workflows and AI-powered submission generation capabilities.
• Freyr Solutions: Freyr provides global regulatory affairs and compliance services for medical devices, pharma, and consumer products, including EU Authorized Representative services. It competes with both Arazy Group's LICENSALE expert services and its EU AR offerings.
• Greenlight Guru: Greenlight Guru is a MedTech-specific QMS and regulatory affairs platform serving medical device companies with eDMS, design controls, and submission management. It competes directly with Arazy Group's SaaS offering for in-house regulatory teams at device manufacturers.
• ProPharma Group: ProPharma Group provides regulatory affairs, quality compliance, and consulting services for medical device and pharma manufacturers, including EU MDR/IVDR support. It is a direct competitor to Arazy Group's LICENSALE expert services business.
• MasterControl: MasterControl provides a quality management system (QMS) and regulatory information management platform widely used by MedTech manufacturers for compliance and product lifecycle management. It is a direct competitor to Arazy Group's REGISLATE platform in the medical device regulatory software space, particularly for customers seeking integrated QMS + RIM.
• Rimsys: Rimsys is a regulatory information management platform purpose-built for medical device and IVD manufacturers, offering submission tracking, registration management, and global market access workflows. It is among the closest direct competitors to Arazy Group's REGISLATE platform.

Broad incumbents

• IQVIA: IQVIA is a large clinical and regulatory services provider serving pharma and MedTech with technology platforms for submissions, compliance, and market access. It overlaps with Arazy Group's regulatory consulting and software offerings as a broader incumbent.
• Veeva Systems (Vault RIM): Veeva's Vault RIM and Vault Quality suites serve large life sciences companies with regulatory information management, submission publishing, and quality workflows. While Veeva primarily focuses on pharma, its Vault platform competes for the same enterprise RIM budget that Arazy Group targets in MedTech.

Market position

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

• Facebookfacebook.com/Arazygroup
• LinkedInlinkedin.com/company/arazy-group
• Instagraminstagram.com/arazy_group
• Xx.com/arazygroup

Compliance1 record

Revenue estimate

Valuation estimate

Number of profiles

Profiles1 record

Funding overview

Funding rounds1 record

Investors1 record

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Arazy Group